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Exercise Therapy and Jaw-Mobilizing Device for Trismus in Head and Neck Cancer Patients

NCT ID: NCT06719388

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2024-10-31

Brief Summary

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This study evaluates the effects of exercise therapy combined with a jaw-mobilizing device on enhancing quality of life in head and neck cancer patients undergoing radiotherapy.

Detailed Description

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This study investigates the efficacy of exercise therapy combined with a jaw-mobilizing device (ET-JMD) in improving maximal mouth opening (MMO), preventing trismus, enhancing quality of life (QoL), and alleviating trismus-related symptoms in head and neck cancer (HNC) patients undergoing radiotherapy.

Conditions

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Head and Neck Cancers Trismus Radiotherapy Side Effects

Keywords

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Head and Neck Cancer Trismus Radiotherapy-Induced Mouth Opening Limitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomly assigned to one of two parallel groups: the experimental group, which receives exercise therapy combined with a jaw-mobilizing device, or the control group, which receives exercise therapy only. Both groups are followed concurrently throughout the study period.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Participants are unaware of their group allocation (experimental or control) to minimize bias in self-reported outcomes and adherence to the intervention. However, investigators and outcome assessors are not masked due to the nature of the intervention.

Study Groups

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Experimental Group

Participants in the experimental group will receive a combination of exercise therapy and a jaw-mobilizing device. The intervention includes structured exercise therapy sessions and the use of the jaw-mobilizing device for 12 weeks, beginning one week prior to radiotherapy. Follow-ups will occur at weeks 16, 24, and 36 to assess outcomes.

Group Type EXPERIMENTAL

combination of exercise therapy and a jaw-mobilizing device

Intervention Type BEHAVIORAL

Participants in the experimental group will receive a combination of exercise therapy and a jaw-mobilizing device. The intervention includes structured exercise therapy sessions and the use of the jaw-mobilizing device for 12 weeks, beginning one week prior to radiotherapy. Follow-ups will occur at weeks 16, 24, and 36 to assess outcomes.

Control Group

Participants in the control group will receive exercise therapy only. This intervention involves the same structured exercise therapy sessions as the experimental group for 12 weeks, beginning one week prior to radiotherapy. Follow-ups will occur at weeks 16, 24, and 36 to assess outcomes.

Group Type PLACEBO_COMPARATOR

exercise therapy only

Intervention Type BEHAVIORAL

Participants in the control group will receive exercise therapy only. This intervention involves the same structured exercise therapy sessions as the experimental group for 12 weeks, beginning one week prior to radiotherapy. Follow-ups will occur at weeks 16, 24, and 36 to assess outcomes.

Interventions

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combination of exercise therapy and a jaw-mobilizing device

Participants in the experimental group will receive a combination of exercise therapy and a jaw-mobilizing device. The intervention includes structured exercise therapy sessions and the use of the jaw-mobilizing device for 12 weeks, beginning one week prior to radiotherapy. Follow-ups will occur at weeks 16, 24, and 36 to assess outcomes.

Intervention Type BEHAVIORAL

exercise therapy only

Participants in the control group will receive exercise therapy only. This intervention involves the same structured exercise therapy sessions as the experimental group for 12 weeks, beginning one week prior to radiotherapy. Follow-ups will occur at weeks 16, 24, and 36 to assess outcomes.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 20 years.
* Ability to communicate in Mandarin or Taiwanese, without significant reading, hearing, or writing impairments, and capable of completing questionnaires independently or with researcher assistance.
* Diagnosed with head and neck cancer and scheduled for initial radiotherapy to the head and neck region.
* Clear consciousness without severe cognitive or psychiatric disorders.
* Presence of intact central incisors (#11, #41) on the right side or (#21, #31) on the left side of both the upper and lower jaws.
* Baseline maximal mouth opening (MMO) ≥ 25 mm.
* Willingness to participate in the study with signed informed consent.

Exclusion Criteria

* Known temporomandibular joint disorders.
* Postoperative wound healing complications diagnosed by a physician that prevent participation in mouth-opening rehabilitation exercises.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Tsai-Wei Huang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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tri-Service Gereral Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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Jaw-Mobilizing Device

Identifier Type: -

Identifier Source: org_study_id